Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:56 AM
Ignite Modification Date:
2025-12-25 @ 12:56 AM
NCT ID:
NCT01901367
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of pre-B cell or T cell ALL and in continuous first remission; at least 3 months into maintenance therapy with at least 7 months remaining before therapy completion
* English speaking patient and primary caregiver
* BMI \>= 75th percentile at time of study enrollment; (patients \>= 75th percentile were selected as they were the group in our preliminary data that had a high risk of becoming overweight during maintenance therapy)
* Provision of informed consent by primary caregiver
Exclusion Criteria:
* Any physical or mental limitation that would prevent participation in study activities (Including but not limited to grade 4 neuropathy or inability to ambulate)
* As this is intended to be a family-based intervention, all family members will be invited to participate, including those living in more than one household, however endpoints will only be assessed formally in the patient and identified primary caregiver; siblings are not required for participation.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
18 Years
Study:
NCT01901367
Study Brief:
Protocol Section:
NCT01901367